Utilizing SaMD software as a medical device development resource is the way to go if you’re looking to diagnose, treat, or participate in condition monitoring and management. The beneﬁts of SaMD software is vast, especially when it comes to digital therapeutics. With SaMD, you can generate and feed highly relevant clinical data across various medical devices and products. The features associated with SaMD lead to solutions that can easily be infused with healthcare workﬂows, from treatment to monitoring ailments.
Trends in healthcare are also leading to an increase in digital therapeutics and a range of digital health technologies to accompany such practices.
Reliable MedTech and digital healthcare software are a must for healthcare professionals, so using SaMD software as a medical device is crucial. However, many beneﬁts that accompany SaMD software still come with some challenges. To touch on some of these challenges and how to create successful SaMD products, we’ve laid out the best practices from experts at Star’s HealthTech Practice. Not only have they authored the 7 considerations for creating successful SaMD, but they’ve also helped experts in the industry integrate software into their workﬂows.
Here’s a summary of how to handle SaMD development at the base level:
- Set business goals around compliance
When you’re in the ﬁrst stages of using the software as medical device development, the best practices to follow lie within guides. Proper SaMD products comply with medical device regulations early on. Adhering to guidelines will save you a lot of time and money, whether you’re looking to build a web-based platform or not. While the regulatory bodies have not yet perfected the documentation associated with SaMD development organizations, there’s enough to help you set business goals and succeed at the base level. Have a look at the following documents released by the International Medical Device Regulators Forum (IMDRF):
- General Principles of Software Validation
- FDA Pre & Post Market Cybersecurity Guidance
- Content of Premarket Submissions for Device Software Functions
Also, remember, to be a respected voice in the space, you’re going to need to uphold patient safety. Familiarize yourself with the following standards: IEC 62304, ISO 13485, IEC 62366, and ISO 14971. Then you’ll be one step closer to properly using SaMD software as a medical device development resource.
- Plan accordingly
Being in the business of medical devices is not for the faint of heart, so you’ll want to ensure you have an all-star team. Hire the right people for your software development plan. Doing so will lay the foundation for your engineering teams to dive into the project. Potential hires can range from UI/UX Designers to Product Managers, depending on your overall goals for the product. Be sure to hire wisely!
- Developing software as a medical device development resource
The right development partner knows how vital cloud-based software is. The possibilities are endless, including the ability to scale system resources for clients. One of the best things engineers can do is generate user interfaces, making the jobs of medical device product teams much easier. Star also recommends prepping the MVP for clinical evaluation.
Innovation always starts somewhere
The key to success in navigating the complexities associated with the development of SaMD products while staying compliant. From condition monitoring to clinical decision support, choosing SaMD software as a medical device development resource is the future of healthcare. Anyone looking to disrupt the space will ﬁnd solace when embracing digital solutions in their overall strategy and design.